510(k) · Cleared
ClearedCannulated Screw and Kirschner (K wire) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthonovis, Inc. · HWC Screw, Fixation, Bone
Cleared on Oct 2, 2025 as substantially equivalent to K130613 (Laura Cattabriga, 2014) and 2 other predicates after a 34-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Oct 2, 2025
- Review
- 34 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K000684 (2000). 103 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet.
- Root · 9 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations between
- 3 generations backK110086 Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011
- 2 generations backK130614 Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga · 2014
- 1 generation backK250055 BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc. · 2025
- This deviceK252758 Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 8 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
- 7 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
- 6 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
- 5 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
- 4 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
- 3 generations backK110086 Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc. · 2011
- 2 generations backK130614 Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga · 2014
- 1 generation backK250055 BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc. · 2025
- This deviceK252758 Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −8 | K011335 | Synths One-Third Tubular DCL Plate | Synthes (Usa) | 2001 | 2 |
| −7 | K012655 | Congruent Bone Plate System | Acu Med, Inc. | 2001 | 16 |
| −6 | K021626 | Hallu Plates | New Deal, S.A. | 2002 | — |
| −5 | K040907 | Arthrex Small Fragment Plates and Screws | Arthrex, Inc. | 2004 | — |
| −4 | K052614 | Low Profile Plate and Screw System | Arthrex, Inc. | 2005 | — |
| −3 | K110086 | Ifs Profile Plates, Screws, and Washers | Internal Fixation Systems, Inc. | 2011 | — |
| −2 | K130614 | Bone Fragment and Fixation Plates, Screws and Washers | Laura Cattabriga | 2014 | — |
| −1 | K250055 | BPS - Bone Fragment Fixation Plates, Screws and Washers | Orthonovis, Inc. | 2025 | — |
| 0 (this device) | K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 8 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130613 | Cannulated Screw and Kirschner (Kwire) SystemSummary page 5…Product Code(s) HWC, HTY, HTN | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K130613 Cannulated Screw and Kirschner (K wire) System HTN K250055 BPS - Bone Fragment Fixation Plates, Screws, and Washers HWC K231504 T… | 2014 |
| * | K250055 | BPS - Bone Fragment Fixation Plates, Screws and WashersSummary page 5…Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K130613 Cannulated Screw and Kirschner (K wire) System HTN K250055 BPS - Bone Fragment Fixation Plates, Screws, and Washers HWC K231504 TITANEX™ MICROBEAM Screw System, TITANEX™ HWC ARTEMIS Screw… | 2025 |
| * | K231504 | TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemSummary page 5…y Predicate is listed first) Product Code K130613 Cannulated Screw and Kirschner (K wire) System HTN K250055 BPS - Bone Fragment Fixation Plates, Screws, and Washers HWC K231504 TITANEX™ MICROBEAM Screw System, TITANEX™ HWC ARTEMIS Screw System Device Description Summary 21 CFR 807.92(a)(4) Cannulated S… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 17 of the 103 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252758: Cannulated Screw and Kirschner (K wire) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252758
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026